Recombinant Factor VIIa

Recombinant factor VIIa is a preparation of activated coagulation factor VII (factor VIIa) that is produced by recombinant DNA technology. The drug expedites blood coagulation without the need for factors VIII and IX in patients with haemophilia. Indicators of activation of systemic coagulation of blood were unchanged and mean prothrombin times and activated partial thromboplastin times were decreased substantially after administration of recombinant factor VIIa at doses of up to 90 microg/kg in pharmacodynamic studies. Recombinant factor VIIa has been shown to be effective at doses ranging from 17.5 to 120 microg/kg in the control of joint, muscle and mucocutaneous bleeding in patients with haemophilia A or B with inhibitors of factor VIII or IX. Satisfactory postoperative haemostasis was achieved in all patients with haemophilia and inhibitors of factors VIII and IX who received multiple doses of recombinant factor VIIa 90 microg/kg during and after surgery. The drug has also demonstrated some efficacy in the control of internal or CNS bleeding in small numbers of patients. Self-administration of recombinant factor VIIa or administration by caregivers has been used successfully to control bleeding episodes in patients with haemophilia without the need for hospital or clinic admission in home treatment programmes in 3 countries. Recombinant factor VIIa is well tolerated. No thrombotic complications have been reported, and there is no evidence to date of the formation of antibodies to the drug in patients with haemophilia A or B or acquired inhibitors of factor VIII or IX.